Drug persistence and need for dose intensification to adalimumab therapy; the importance of therapeutic drug monitoring in inflammatory bowel diseases

BMC Gastroenterology

Research Article

Balazs Szalay¹  Lorant Gonczi²  Zsuzsanna Kurti²  Zsuzsanna Vegh²  Krisztina B. Gecse²  Petra A. Golovics²  Peter L. Lakatos³  Barbara D. Lovasz⁴  Mariann Rutka⁵  Tamas Molnar⁵  Klaudia Farkas⁵ 

[1]Department of Laboratory Medicine, Semmelweis University, Budapest, Hungary

[2]First Department of Medicine, Semmelweis University, Koranyi S 2A, H-1083, Budapest, Hungary

[3]First Department of Medicine, Semmelweis University, Koranyi S 2A, H-1083, Budapest, Hungary

[4]Division of Gastroenterology, McGill University, MUHC, Montreal General Hospital, 1650 Ave. Cedar, D16.173. 1, H3G 1A4, Montreal, QC, Canada

[5]First Department of Medicine, Semmelweis University, Koranyi S 2A, H-1083, Budapest, Hungary

[6]Institute of Applied Health Sciences, Semmelweis University, Budapest, Hungary

[7]First Department of Medicine, University of Szeged, Szeged, Hungary

关键词: Adalimumab;    Therapeutic drug monitoring;    Inflammatory bowel diseases;    Loss of response;   

DOI  :  10.1186/s12876-017-0654-1

 received in 2017-04-26, accepted in 2017-07-31,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundTherapeutic drug monitoring (TDM) aid therapeutic decision making in patients with inflammatory bowel disease (IBD) who lose response to anti-TNF therapy. Our aim was to evaluate the frequency and predictive factors of loss of response (LOR) to adalimumab using TDM in IBD patients.MethodsOne hundred twelve IBD patients (with 214 TDM measurements, CD/UC 84/28, male/female 50/62, mean age CD/UC: 36/35 years) were enrolled in this consecutive cohort from two referral centres in Hungary. Demographic data were comprehensively collected and harmonized monitoring strategy was applied. Previous and current therapy, laboratory data and clinical activity were recorded at the time of TDM. Patients were evaluated either at the time of suspected LOR or during follow-up. TDM measurements were determined by commercial ELISA (LISA TRACKER, Theradiag, France).ResultsAmong 112 IBD patients, LOR/drug persistence was 25.9%/74.1%. The cumulative ADA positivity (>10 ng/mL) and low TL (<5.0 μg/mL) was 12.1% and 17.8% after 1 year and 17.3% and 29.5% after 2 years of adalimumab therapy. Dose intensification was needed in 29.5% of the patients. Female gender and ADA positivity were associated with LOR (female gender: p < 0.001, OR:7.8 CI 95%: 2.5–24.3, ADA positivity: p = 0.007 OR:3.6 CI 95%: 1.4–9.5).ConclusionsADA development, low TL and need for dose intensification were frequent during adalimumab therapy and support the selective use of TDM in IBD patients treated with adalimumab. ADA positivity and gender were predictors of LOR.

【 授权许可】

CC BY   
© The Author(s). 2017